University of Illinois at Chicago
Chicago, Illinois, 60612-7316, United States
Location status: Recruiting
Location contact
Kylea L Liese, PhD
CONTACT
Stacie Geller, PhD
CONTACT
NCT Number: NCT05365815
This study is being conducted to determine if a multi-level intervention for delivering maternity care can improve patient trust and engagement among Black birthing people.
Interested in participating?
Request Info15 year–49 year
Female
Interventional
Not applicable
Chicago, Illinois, 60612-7316, United States
Location status: Recruiting
Kylea L Liese, PhD
CONTACT
Stacie Geller, PhD
CONTACT
Low-risk pregnant participants will be randomized into Melanated Group Midwifery Care or usual individualized obstetric care. In Melanated Group Midwifery Care (MGMC), Black women will receive prenatal care from a Black midwife in groups with the same 8-10 other Black women throughout pregnancy. In pregnancy and into the first year postpartum, MGMC patients will stay connected to the health system through a proactive care coordinator, who is a Black licensed nurse. For the first year after giving birth, patients in MGMC will also be supported by a trained postpartum doula.
All participants (intervention and usual care groups) will complete study measures that include validated surveys on patient trust, respect and engagement at 6 time points:
The investigators will also document how MGMC gets embedded in practice through a qualitative process evaluation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients:
Inclusion criteria
for providers:
Exclusion criteria
for patients:
Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support
Time frame: Birth (T3)
Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records
Time frame: Birth (T3)
Five tests completed during prenatal period (yes/no), documented in electronic medical record
Time frame: 1 year postpartum (T6)
Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record
Time frame: Change from baseline through 12 months postpartum (T6)
Patient Activation Measure (PAM), 13-item scale, range 0-100, Likert disagree strongly to agree strongly and not applicable. Assesses degree to which individuals take an active role in managing health and health care. Higher scores are more likely to understand that their active involvement is critical to their state of health and considered more ''in charge.'' The PAM has strong psychometric properties and is predictive of a wide range of health-related behaviors. Hibbard et al. report that a 4-point difference in PAM scores can be viewed as clinically significant.
Time frame: Change from baseline through 12 months postpartum (T6)
Mothers Autonomy in Decision-Making Scale. 7 item scale, Likert completely disagree to completely agree. Assesses the degree to which patients were given decision-making for healthcare decisions, and if patients felt respected by providers. Higher scores indicate that providers supported patient autonomy and patient decision-making.
Time frame: Change from baseline through 12 months postpartum (T6)
Trust in Physician Scale, 11 items, range 11-55, Likert 1-5; α =0.85-0.90.
Time frame: Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
22 items; 5-point Likert (excellent to poor); α =0.95. Excellent reliability and construct validity, taps six established dimensions of satisfaction (art of care, technical quality, access, physical environment, availability, and efficacy)
Time frame: Change from baseline through 12 months postpartum (T6)
Computerized Adaptive Testing - Mental Health: assessing depression, anxiety, suicidality, substance use disorder, and social determinants of health.
Time frame: Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
Mothers on Respect index (MORi) quantifies women's sense of disrespect and dismissal when engaging in conversation with providers, 14 items, Likert, ranging from 1-strongly disagree to 6-strongly agree. α =0.94
Time frame: 12 months postpartum (T6)
Referrals to higher acuity medical or obstetric care
Time frame: 12 months postpartum (T^)
Referrals to higher acuity mental health or social services
Contact information is provided by the study sponsor or research team.
University of Illinois at Chicago
Other
Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism
Acronym: MGMC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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